- Weekly cisplatin plus radiotherapy (CDDP+RT) is noninferior to CDDP+RT every 3 weeks (q3w) and has a favorable toxicity profile in postoperative high-risk patients with locally advanced squamous cell carcinoma (SCC) of the head and neck (LA-SCCHN).
- Authors: weekly CDDP+RT should be the new standard treatment in this setting.
Why this matters
- CDDP+RT q3w is the standard treatment but raises concerns about toxicity and insufficient adherence.
- Weekly CDDP+RT could lead to better adherence.
- 261 patients were enrolled in the multi-institutional phase 2/3 JCOG1008 trial aimed at testing the noninferiority of the weekly vs q3w regimen in phase 3.
- Patients were randomly assigned to CDDP+RT 100 mg/m2 q3w (66 Gy/33Fr; n=132) or CDDP+RT 40 mg/m2 weekly (66 Gy/33Fr; n=129).
- Primary endpoints: proportion of treatment completion (phase 2), and OS (phase 3).
- 93.2% in q3w group completed treatment vs 86.8% in weekly group.
- At a planned second interim analysis in phase 3, the Data and Safety Monitoring Committee recommended terminating the trial because the statistical boundary for OS noninferiority had met the prespecified stopping criteria.
- 3-year OS:
- 59.1% in q3w group vs 71.6% in weekly group.
- HR, 0.69 (one-sided P for noninferiority=.00272).
- Better relapse-free survival, better local relapse-free survival, and a favorable safety profile were observed with weekly CDDP+RT.
- National Cancer Center.
- Japan Agency for Medical Research and Development.
- Imbalance in patient characteristics between groups.
- No adjustments for TNM and human papillomavirus status.
- “These results represent a significant achievement,” said Hisham Mehanna, Director, Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, UK. “It is now important to investigate the longer-term toxicity profile and whether there is a superiority of weekly arm with longer follow-up.”